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Alerts, Recalls, and Legal Headlines

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Australian Study Confirms HPV Vaccine is Working; Call for Higher Vaccination Rates in the U.S.

3/28/2014

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The results of a longterm Australian study recently published in the British Medical Journal showed a clear association between human papillomavirus (HPV) vaccination and significantly reduced risk of developing  cervical abnormalities.  Girls and young women who received all three recommended does of the vaccine had a 46% reduction in the risk of high-grade cervical lesions and a 34% reduction in the risk of all other cervical abnormalities.  

In the U.S., every year 14 million people are newly infected and 26,000 cancers attributable to HPV are diagnosed. Four leading U.S. medical organizations - the American Academy of Family Physicians (AAFP), the American Academy of Pediatrics (AAP), the American College of Physicians (ACP), and the American College of Obstetricians and Gynecologists (ACOG) - together with the Immunization Coalition and the Centers for Disease Control and Prevention, have issued a joint statement calling on U.S. physicians to strongly recommend the vaccination to their patients, especially adolescent girls and boys.  Currently only 30% of eligible girls and young women in the U.S. have received the HPV vaccination.

[1] Crowe, E. "Effectiveness of quadrivalent human papillomavirus vaccine for the prevention of cervical abnormalities: case-control study nested within a population based screening programme in Australia" BMJ 2014; 348:g1458.

[2] AAFP Press Release: "Leading Medical and Public Health Organizations Join Efforts Urging Physicians to Strongly Recommend Human Papillomavirus (HPV) Vaccination"  (Feb. 12, 2014). 

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CDC Study Shows Flu Vaccine Reduced Life-Threatening Flu in Children by 74%-82%

3/28/2014

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A study by the Centers for Disease Control and Prevention (CDC) published online this week  found the flu vaccine was effective in significantly reducing cases of life-threatening flu in children.  The study analyzed vaccination records and data from 44 cases of children admitted to 21 U.S. pediatric intensive care units (PICUs) with acute severe respiratory illness and testing positive for flu during the 2010-11 and 2011-12 flu seasons.   These cases were compared to 172 PICU controls (children in the PICUs without the flu) and 93 community controls (children in the community without the flu).  The study found that children fully vaccinated against the flu were 74% or 82% less likely to be admitted to a PICU with s life-threatening flu illness compared to PICU controls or community controls, respectively.  Children who only received one dose of vaccine when two doses were recommended were not protected.
[1] Ferdinands, et al. "Effectiveness of influenza vaccine against life-threating RT-PCR-confirmed influence illness in U.S. children, 2010-2012," J. Infect. Dis. (2014) doi: 10.1093/infdis/jiu185 (published online March 26, 2014).

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Recall: Gardasil ® HPV Vaccine 

12/23/2013

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On December 16, 2013 CDC was informed by Merck that the company planned to implement a voluntary recall of one lot (lot J007354) of Gardasil® [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant], due to the potential for a small number of vials to contain glass particles as a result of breakage during the manufacturing process.  Gardasil® is a vaccine recommended for 11-12 year olds in order to prevent human papillomavirus (HPV), a virus that causes cervical cancer.  If a person received a vaccine containing glass particles, mild reactions such as swelling at the injection site may occur.  The effectiveness of the vaccine is not affected by this problem.  The affected vials were distributed between August 20, 2013, and October 9, 2013. 
[1] CDC, "Voluntary Recall of One Lot of Gardasil HPV Vaccine" (December 20, 2013).
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Recall: One Lot of Gardasil May Contain Glass Particles

12/23/2013

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Last week Merck & Co., the manufacturer of Gardasil, recalled one lot of the vaccine because a limited number of the vials in the lot may contain glass particles.   Gardasil is a vaccine that protects against the human papillomavirus (HPV), a sexually transmitted disease that causes about 70% of cervical cancer cases and 90% of genital warts cases.  The affected vials were distributed between Aug. 20 - Oct. 9, 2013.  If a patient received a vaccine containing glass, he or she may experience mild redness or swelling near the injection site.  

[1] FDA Biologics Recall of GARDASIL [Dec. 19, 2013]
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Recall: One Lot of MENVEO Vaccine May Contain Moisture

12/4/2013

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Novartis Vaccines has implemented a voluntary market recall of one lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine. This action is being taken following the observation of higher-than-specified levels of residual moisture within a vial in the lot. This residual moisture content is not expected to impact product quality, but constitutes a deviation of the required quality standards and the vaccine is being recalled as a precaution.

[1] FDA Biologics Recall [Dec. 2, 2013].
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Recall: RECOMBIVAX HB

6/28/2013

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Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck), has initiated a voluntary recall due to the potential for a limited number of cracked vials to be present in Lot J001183, distributed by Merck between March 12, 2013 and May 2, 2013.
 
Merck’s investigation concluded that for certain vials in the affected lot, the potential exists for a crack to have occurred in the vial. If the vial was cracked, the integrity of the vial and the sterility of any product remaining in the vial cannot be assured. If product from this lot has been administered, revaccination is not necessary.  Lot J001183 of RECOMBIVAX HB Adult Formulation is the only lot impacted by the recall and was distributed solely within the United States. 

[1] FDA, "Recall of RECOMBIVAX HB [Hepatitis B Vaccine (Recombinant)] (June 26, 2013).


 
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